Study to Investigate the Effect of AB-101 in Breast Cancer Survivors

The purpose of this research study is to investigate the possibility that a topical drug could restore nipple sensitivity and improve sexual quality of life in breast cancer survivors.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Sexual Dysfunction; Sexual Dysfunction, Physiological; Neuropathy; Cancer of Breast; Sexual Arousal Disorder; Nipple Disorder
• Intervention / Treatment: Drug: AB-101; Drug: Placebo

Detailed Description

Approximately, 80% of breast cancer survivors undergoing will suffer from a permanent reduced reduction in nipple sensitivity and associated lowerdecrease in sexual quality of life. Currently, there are no treatments for restoring nipple sensitivity and the associatedto improve lower sexual quality of life this condition. It would thus be of great clinical benefit to post breast surgery patients if a provide a new safe and , effective , topical , on-demand, treatment for this condition can be developed.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Southern CA Center for Sexual Health and Survivorship Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female breast cancer survivor
• Age: 18 to 70
• First diagnosed with Stage I or II breast cancer
• Have had breast surgery: nipple sparring mastectomy or lumpectomy
• At least 3 years post surgery
• Nipple neuropathy post breast surgery (change in Llikeart scale >= 3 between pre and post surgery)
• Baseline nipple sensitivity <=5 (likeartLikert scale)
• QoL-BC (>=7)
• Delayed orgasm (CTCAE v4.0) Grade 2
• One of the following: Delayed orgasm (CTCAE v4.0) Grade 2 and/or Vaginal dryness (CTCAE v4.0) Grade 2 or 3
• Able to give informed consent
• Currently in a monogamous heterosexual relationship for at least 12 months
• Sexually active within the last 30 days
• Willing to engage in sexual activity at least once a month during the duration of the study
• Willing to use on a regular basis a web based form system to record sexual events i.e., have access to the Internet
• Willing to use an adequate method of birth control
• Able to comply with the study requirements for 8 consecutive weeks
• Able to give informed consent

Exclusion Criteria:

• Previous adverse event to alpha 1 agonists (oral, nasal, topical, or ocular) or drugs in this class
• Currently pregnant
• Nursing within the last 6 months prior to beginning the study
• History of cardiovascular or cerebrovascular disease, e.g., heart attack, disease of the arteries of the heart, partial heart block, rapid ventricular heartbeat, slow heartbeat, chronic heart failure, severe hardening of the arteries, blood clot in an artery
• Actively being treated for breast cancer
• Changes in chronic medication for oncology, cardiology, or endocrinology in past 12 months
• Uncontrolled or severe hypertension
• Decreased oxygen in the tissues or blood
• Active inflammation of the liver
• Acute inflammation of the pancreas
• Overactive thyroid gland
• Acidosis
• Diabetes
• Spinal cord injury
• Nipple dermatitis
• Regional complex pain syndrome
• Use of any hypertensive drugs
• Use of MAO inhibitors
• Subjects assigned to interventional drug arm and failed to report an increase >=2 from baseline in nipple sensitivity (likert scale) during phase I
• In partners: sexual dysfunction or erectile dysfunction
• Currently enrolled in any other medical study or has been enrolled in any medical study in the past 30 days
• Nipple dermatitis
• Regional complex pain syndrome
• Unable to provide consent or make allotted clinical visits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AB-101; Apply to both nipple/areola regions approximately 1 hour prior to sexual activity	Drug: AB-101; Apply approximately 1 hour prior to sexual activity; Other Names: Phenylephrine
PLACEBO_COMPARATOR: Placebo; Apply to both nipple/areola regions approximately 1 hour prior to sexual activity	Drug: Placebo; Apply approximately 1 hour prior to sexual activity; Other Names: Vehicle Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Delayed Orgasm Grade	Change in Delayed Orgasm Grade (CTCAE v4.0 - Common Terminology of Adverse Events) CTCAE v4.0 is the NIH Common Terminology of Adverse Events v4.0 Delayed Orgasm is defined as: A disorder characterized by sexual dysfunction characterized by a delay in climax. This is a binary grading system: Grade 0:Delay in achieving orgasm not adversely affecting relationship Grade 1:Delay in achieving orgasm adversely affecting relationship	[baseline, week 8]

Collaborators and Investigators

• Sponsor: Applied Biology, Inc.
• Investigators: Principal Investigator: Michael Krychman, MD, Southern CA Center for Sexual Health and Survivorship Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 9, 2018
• Primary Completion (ACTUAL): October 12, 2019
• Study Completion (ACTUAL): October 12, 2019

Study Registration Dates

• First Submitted: July 8, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (ACTUAL): July 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Nipple Neuropathy, Cancer Survivor
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Disease; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Respiratory System Agents; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Nasal Decongestants; Adrenergic alpha-1 Receptor Agonists; Phenylephrine
• Other Study ID Numbers: RJ-101-RCT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No